Chronic Pain, Chronic Pain Syndrome
Conditions
Brief summary
Chronic pain syndromes without identified organic etiology remain a challenge for physicians. Many syndromes, including back pain, are believed to have potential underlying psychological etiology; however, the exact link remains elusive. The goal of this study is to determine if mind body therapies can help people suffering from chronic back pain. The study is a randomized, partially blinded trial examining the effectiveness of Mind Body Syndrome Therapy (MBST) in reducing disability from back pain and alleviating back pain. The investigators will secondarily investigate whether MBST can improve participant quality of life and reduce the need for pain-related hospitalization. The design of the this study consists of 3 arms with one being the intervention (MBST), one being usual care, and one being a second mind-body intervention (active control). This education program consists of a series of personal interviews and group and/or individualized lectures/sessions. Participants will also be provided reading material to study during the intervention period, and asked to continue their usual care while going through the MBST program.
Interventions
BEHAVIORALMind Body Intervention 1: Mind-Body-Syndrome-Therapy (MBST)
Mind body techniques for Intervention 1 will be taught in lectures and group discussion sessions.
BEHAVIORALMind Body Intervention 2
Mind body techniques for Intervention 2 will be taught in lectures and group and/or individual sessions.
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participants will be partially blinded. Participants in the usual care arm will be blinded to the specifics of the interventions. Intervention participants will be blinded to the specifics of the intervention until after they have been randomized into that arm. Data analysis will be conducted by persons who are completely blinded.
Intervention model description
Usual Care, Intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patient 18 \> years old * Chronic back pain * Pain persistent for ≥3 days/week for the past 3 months prior to enrollment * Willingness to consider mind-body intervention
Exclusion criteria
* Patients \< 18 years of age * Diagnosed organic disease as cause of pain, such as (but not limited) to malignancy, neurologic disorder (i.e., amyotrophic lateral sclerosis), cauda equina syndrome. Pain related to disc disease is not an exclusion unless there are neurological impairments. * Patients with a diagnosis of significant psychiatric co-morbidities such as schizophrenia, dementia and bipolar disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Disability: Roland Morris Disability Index | change over 26 weeks | Change in the Roland Morris Disability Index (Scale 0-24 with 24 being worst) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Bothersomeness (Back Specific): Brief Pain Inventory Survey | 4 weeks, 8 weeks, 13 weeks, 26 weeks | Back pain bothersomeness as determined from modified Brief Pain Inventory Survey. (Scale 0-10 with 10 being the worst) |
| Pain Bothersomeness: Brief Pain Inventory Survey | 4 weeks, 8 weeks, 13 weeks, 26 weeks | Whole-body pain bothersomeness as determined from modified Brief Pain Inventory Survey (Scale of 0-10 with 10 being the worst) |
| Pain affecting enjoyment of life | 4 weeks, 8 weeks, 13 weeks, 26 weeks | Scale 0-10 with 10 being worst from Brief Pain Inventory |
| Average Pain: Brief Pain Inventory Survey | 4 weeks, 8 weeks, 13, weeks, 26 weeks | Average pain as determined in the Brief Pain Inventory Survey (Scale 0-10 with 10 being worst) |
| Pain-related hospital admissions | 26 weeks | Self reported. Number of pain-related hospital admissions, including emergency room visits |
| Complete resolution of pain disability: Roland Morris Disability | 4 weeks, 8 weeks, 13 weeks, 26 weeks | complete resolution of pain disability as measured by Roland Morris Disability (Scale 0-24 with 24 being worst) |
| Anxiety from pain: Pain Anxiety Symptom Scale-20 survey | 4 weeks, 8 weeks, 13 weeks, 26 weeks | Anxiety from pain as determined from the Pain Anxiety Symptom Scale-20 survey (20 questions with scale of 0-5 with 5 being 'always' and 0 being 'never' |
Countries
United States
Outcome results
None listed